510(k) K905048

ACE 3.5MM CORTICAL BONE SCREW by Ace Medical Co. — Product Code HWC

K905048 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE 3.5MM CORTICAL BONE SCREW". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ace Medical Co. has at least 10 other 510(k) clearances on record.